NCT05816213Not yet recruiting
Point-of-care Low-field MRI in Acute Stroke
Point-of-care Low-field Magnetic Resonance Imaging in Acute Stroke (POCS) Study
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Consecutive patients accessing the emergency department with suspected stroke dispatch will be recruited at 3 study units: 1) ASL Abruzzo 1, hospitals of L'Aquila and Avezzano; 2) ASL Abruzzo 2, hospital of Chieti; 3) IRCCS Humanitas Research Hospital of Milan. Anonymized clinical and low-field (LF) MRI data as well as conventional neuroimaging data will be independently assessed by external units (Università Politecnica delle Marche and Policlinico di Messina, respectively). Both units will independently adjudicate the best treatment option, while the latter will also provide historical MRI data of stroke patients to develop artificial intelligence algorithms facilitating LF-MRI images interpretation (Libera Università di Bolzano). Agreement with conventional neuroimaging will be evaluated at different time points (hyperacute, acute -24 h, subacute -72 h, discharge, chronic -4 weeks). Further investigations will include feasibility study to develop an ambulance (mobile stroke unit) equipped with LF-MRI and cost-effectiveness analysis of LF-MRI. This trial will provide necessary data to validate the use of LF-MRI in the acute stroke care.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 3 Apr 2023
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of L'Aquila
- Diseases
- Stroke
- NCT number
- NCT05816213
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Feb 2025 to the primary completion date, 1 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- implanted ferromagnetic devices potentially interfering with LF-MRI (e.g. cochlear implants);
Other illness
- symptoms not indicative of acute stroke (e.g. syncope, tonic or clonic activity, dizziness or wooziness alone, confusion and amnesia alone, subacute or chronic development of a focal neurological deficit);
Other
- inability to undergo LF-MRI due to critically impaired vital functions (e.g. hemodynamically unstable patients, need of immediate life-saving maneuvers);
- impossibility to achieve written informed consent.
Who the study is looking for
- symptoms suggestive of acute stroke (acute onset of a focal neurological deficit which can be referred to the involvement of a specific CNS region);
- stroke onset \<24 h since when the patient was last known healthy;
- written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired or aphasic).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SS Filippo e Nicola Hospital of Avezzano Coordinator of this site? Confirm its status | Avezzano | Italy | Unknown status |
| SS Annunziata Hospital of Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| S Salvatore Hospital of L'Aquila Coordinator of this site? Confirm its status | L’Aquila | Italy | Unknown status |
| IRCCS Humanitas Research Hospital of Rozzano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.